# FDA recall D-0902-2018

> **SCA Pharmaceuticals, LLC** · Class II · drug recall initiated 2018-06-14.

## Product

Phenylephrine HCL 40 mg in 0.9% Sodium Chloride 250 mL Bag (160 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT

## Reason for recall

Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.

## Distribution

Product was distributed throughout the United States.

## Key facts

- **Recall number:** D-0902-2018
- **Recalling firm:** SCA Pharmaceuticals, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-06-14
- **Report date:** 2018-07-11
- **Termination date:** 2019-02-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Windsor, CT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0902-2018

## Citation

> AI Analytics. FDA recall D-0902-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0902-2018. Source: US FDA. Licensed CC0.

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